FDA recall, , High risk
Medline Hip and Knee Procedure Kits
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.
Summary by Recall Canary from the FDA notice
What happened
Medline Industries, LP of Northfield, Illinois, recalled Medline medical procedure convenience kits labeled TOTAL KNEE-LF, TOTAL KNEE CDS, HIP CDS-LF, and TOTAL KNEE PACK, containing ICU Medical, Inc. pain management kits with Bupivacaine Hydrochloride in Dextrose Injection, USP, due to quality issues that could result in drug ineffectiveness. The recall began June 8, 2026, and was classified by the FDA on July 22, 2026, affecting kits distributed in Colorado and Illinois.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
2 products
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
MEDLINE medical procedure convenience kit labeled as: Hip CDS-LF, Medline kit SKU CDS984556N
- UDI-DI
- 10198459266621
- 40198459266622
- Lot code
- 26EDA285
- 26DDA718
- 26BDB740
- 26ADB079
- 26ADA161
- 25KDB472
- 25GDA213
MEDLINE medical procedure convenience kit
- UDI-DI
- 10195327555009
- 40195327555000
- 10198459180255
- 40198459180256
- 10193489512298
- 40193489512299
- 10195327554996
- 40195327554997
- 10198459180248
- 40198459180249
- 10198459235900
- 40198459235901
- Lot code
- 24GDA740
- 26EDA279
- 26BDB734
- 26ADA474
- 25LDA001
- 25KDB325
- 25GDB517
- 25FDB017
- 25DDA155
- 24LDA248
- 25KBL209
- 24JDC180
- 24HDA321
- 25ADB327
- 26CBD346
- 25KBU219
Recall details
- Company began the recall
- Company
- Medline Industries, LPNorthfield, Illinois
- Hazard
- Device defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 99297
- Recall numbers
- Z-2764-2026 to Z-2765-2026
All recalls from Medline Industries, LP
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Classified by FDA
Added to FDA's Enforcement Report
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
